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Deputy Director, New Vaccines and Projects

Toronto, Canada

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Responsibilities

Deputy Director, New Vaccines and Projects

Reference #: 2474978

Department: Pharmaceutical Sciences & Technology

Location: Toronto, Ontario

About Sanofi Pasteur

Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines.  Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe.  Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.  With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Position Summary:

  • Manage project leaders to lead NV projects, and act as Phase III and post-clinical subject matter expert.  Ensure the quality and compliance of the manufacturing process for clinical product. Liaise with PRD to ensure that directives or recommendations from the global/site are implemented. 
  • Manage project leaders to develop strategies, plan and lead activities related to PPI and INF projects.  Coordinate project deliverables and communication.  Manage projects to ensure that timelines and quality aspects are met.
  • Ensure validation master plans, project outlines or technology transfer plans are written, and collect and integrate inputs from production, quality assurance and other key stakeholders.  Communicate resource requirements to appropriate functions.
  • Support Manufacturing by performing investigations or root cause analysis.
  • Ensure that studies are based on scientifically sound principles.  Review relevant literature and/or obtain input from subject matter experts.  Share knowledge and area of expertise to support projects and stay abreast of current advances in area of technical expertise.
  • Act as a delegate for Platform Head.

Job Accountabilities:

  • Responsible for project estimations, budgets, resources, major deliverables, quality of deliverables, gate reviews and maintaining project timelines.  Ensure capacity requirements and resources are balanced, and inline with functional, cross-functional and platform constraints. Responsible for project reporting. (15%)
  • Interact with cross functional teams in PRD, Production, Quality Operations and other internal and external groups (France and USA) to support process and technology transfer, scale-up, process improvement and validation. Ensure that strategies developed during scale-up are implemented when appropriate.(25%)
  • Manage project leaders and lead and participate in NV, PPI, MAR and INF project teams, working groups and task forces (local and or global).  Responsible for scientific and technical aspects of assigned projects. (25%)
  • Support project leaders to design, plan and execute experiments to demonstrate robustness, optimize processes and support scale-up and scale-down of manufacturing processes where required by projects.(15%)
  • Ensure project VMPs & process validation protocols are available to support clinical manufacturing processes, & supportive small scale and scale up studies (15%)
  • Support and comply with all Sanofi Pasteur health, safety and environmental policies, contribute toward meeting departmental/platform goals; and demonstrate progress in preventing or reducing injuries and/or illness (5%)

Education:

  • MSc (Science/Engineering) with 7-10 years or Ph.D (Science/Engineering) with minimum 5 years  related experience.  Candidate should posses a familiarity with Regulatory Requirements, a working knowledge of Management , Statistical Process Control (SPC) skills and Six Sigma methodology.
  • PMP an asset.

Experience:

  • 7+ years in industry and project management.
  • Experience and knowledge in capital projects, facility design and startup, C&Q, process.

Key Competencies:

  • Project leadership and project management methodology, including budgeting, cost/benefit analysis, process design, process validation and change management.
  • Establishing and applying structured methodologies, such as Quality by Design (QBD), Design Space, Process Control Strategies.
  • An in-depth knowledge of technical areas specific to manufacturing processes (Formulation, Protein Chemistry, Scale-up, Lyophilization, Adjuvants, Filling/Inspection, Primary Components, Cleaning Validation, Sterilization, Filtration).
  • Effective communication skills, including negotiation, conflict resolution, emotional intelligence; critical thinking and problem solving.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Sanofi, Empowering Life

 #GD-SP          

 #LI-SP

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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